Candin Safety & Efficacy Study for the Treatment of Warts

This study has been completed.

Sponsor:

Nielsen BioSciences, Inc.

ClinicalTrials.gov Identifier:

NCT01757392

First Posted: December 28, 2012

Last Update Posted: December 11, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).

Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.

Biological: Candida albicans Skin Test Antigen

0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.

Other Name: Candin®

Detailed Description:

The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Must have at least 3 and not more than 10 common warts not located on the palms or digits

Positive DTH response to Candin® required

Exclusion Criteria:

No previous medical treatment for warts other than OTC

No immunocompromising medical conditions or medicines allowed

No preexisting inflammatory conditions at treatment site allowed

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757392